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Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer

This study has been completed.
University of Arizona
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 25, 2005
Last updated: May 1, 2013
Last verified: October 2011

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent breast cancer.

PURPOSE: This randomized phase I trial is studying the effects of sulindac, to prevent breast cancer, in women at high risk for breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: sulindac
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase IB Sulindac Study for Women at High Risk for Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment

Secondary Outcome Measures:
  • Prostaglandin (PGE2) levels in NAF before and after 6 weeks of treatment
  • NAG-1 induction and C-reactive protein (CRP) reduction before and after 6 weeks of treatment
  • Magnitude of change and dose response of PGE2, NAG-1, and CRP in NAF before and after 6 weeks of treatment

Estimated Enrollment: 30
Study Start Date: November 2005
Study Completion Date: January 2010
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the partitioning of sulindac and its metabolites in women at high risk for breast cancer by measuring drug and metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of therapy.


  • Determine prostaglandin levels in the NAF of patients treated with this drug.
  • Determine if NAG-1 levels are induced in the NAF of patients treated with this drug.
  • Determine if C-reactive protein levels are reduced in the NAF of patients treated with this drug.
  • Determine if NAG-1 levels and/or karyometric features in ductal epithelial cells are modulated in patients treated with this drug.

OUTLINE: This is a randomized, open-label study.

Patients undergo nipple aspirate fluid (NAF) collection. Patients are then randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sulindac once daily.
  • Arm II: Patients receive oral sulindac twice daily. In both arms, treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. All patients then undergo a second NAF collection.

After completion of study treatment, patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this study.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Meets 1 of the following criteria:

    • Gail assessment score > 1.7% risk for 5 years
    • History of lobular carcinoma in situ (pathology report required)
    • History of ductal carcinoma in situ (DCIS) (pathology report required)
    • History of breast cancer in ≥ 1 first-degree relative or history of BRCA1 or BRCA2 positivity not treated with oophorectomy or mastectomy (test report required)
    • History of breast cancer in ≥ 2 second-degree relatives
    • Any family history of breast cancer diagnosed prior to age 50
    • Personal history of breast cancer (invasive or DCIS) with 1 breast intact
  • Nipple aspirate fluid production ≥ 5 microliters
  • Negative mammogram for breast cancer within the past 10 months

    • Any suspicious breast masses must be examined by a clinical professional
  • Hormone receptor status:

    • Not specified



  • Female

Menopausal status

  • Pre- or postmenopausal

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No history of bleeding or clotting disorder


  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.0 times upper limit of normal
  • No indication of abnormal liver function


  • Creatinine normal


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • No frequent, chronic, or moderate/severe gastric complaint
  • No upper gastrointestinal problems (e.g., symptoms of heartburn, dyspepsia, or abdominal pain) requiring prescription or nonprescription medical remedies more than once per week (on average)
  • No history of peptic ulcer or occult or gross intestinal bleeding


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction (e.g., urticaria, asthma, rhinitis) or gastric intolerance attributed to compounds of similar chemical or biological composition to sulindac
  • No history of allergy attributed to lidocaine, EMLA® cream, or xylocaine
  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No more than 2-3 servings of alcohol per week during study participation



  • More than 6 months since prior chemotherapy for breast cancer (invasive or DCIS)

Endocrine therapy

  • More than 6 months since prior hormonal therapy for breast cancer (invasive or DCIS)
  • No concurrent hormone-suppressing agents (e.g., tamoxifen or anastrozole)
  • No concurrent selective estrogen-receptor modulators
  • No concurrent aromatase inhibitors


  • More than 6 months since prior radiotherapy for breast cancer (invasive or DCIS)


  • See Disease Characteristics
  • No prior breast duct-disrupting surgery (e.g., mastectomy) that would preclude ductoscopy


  • More than 3 months since prior warfarin or other systemic anticoagulant
  • More than 4-6 weeks since prior nonsteroidal anti-inflammatory drugs
  • No concurrent phenytoin or sulfonamides
  • No concurrent warfarin or other systemic anticoagulant
  • No other concurrent nonsteroidal anti-inflammatory drugs (including low-dose aspirin)
  • No concurrent large doses of supplements, vitamins (> regular daily multivitamin) and/or herbal medicines (e.g., echinacea, ginkgo biloba, Hypericum perforatum [St. John's wort], or herbal tea)
  • No other concurrent investigational agents
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Please refer to this study by its identifier: NCT00245024

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
National Cancer Institute (NCI)
University of Arizona
Study Chair: Patricia Thompson, PhD University of Arizona
  More Information

Responsible Party: H. H. Sherry Chow, Arizona Cancer Center at University of Arizona Health Science Center Identifier: NCT00245024     History of Changes
Other Study ID Numbers: CDR0000447144
P30CA023074 ( US NIH Grant/Contract Award Number )
Study First Received: October 25, 2005
Last Updated: May 1, 2013

Keywords provided by National Cancer Institute (NCI):
breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017